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临床试验/CTRI/2023/10/058562
CTRI/2023/10/058562尚未招募不适用

Comparison of two different techniques of analgesia for intravenous cannulation: A randomised controlled study

Dr Shagun Bhatia Shah1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年10月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Pain visual analog scale (VAS)score

研究概览

简要总结

This prospective interventional, two-arm, single-centric randomised controlled study aims to compare a vapocoolant based no-prick technique of preventing pain due to intravenous cannulation with the local anaesthetic injection technique and shall include 80 adult ASA I-II patients of either sex, aged 18-60 years, weighing 45-80kg, undergoing IV cannulation with 20G or 18G cannula. Exclusion criteria comprise patient refusal to give consent, local anaesthetic allergy and patients requiring more than one attempt for intravenous cannulation. The study will be conducted at Rajiv Gandhi Cancer Institute and Research Centre. The patients shall be randomly allocated into two groups: local anaesthetic injection group (Group-LA; n=40), and vapocoolant spray group (Group-VS; n=40). Our primary outcome measures would be pain score measured on a linear 100mm Visual analog scale (VAS) at the time of local anaesthetic prick/vapocoolant spray, intravenous cannula introduction, and 1min post intravenous cannulation. Our secondary outcome measures would be VAS for anxiety score, heart rate (HR), mean arterial pressure (MAP) and perfusion index (PI) measured at specific time points (baseline, intravenous cannula introduction, and 1min post intravenous cannulation).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Weighing 40-80kg, undergoing intravenous cannulation with 20G or 18G cannula.

排除标准

  • Refusal to give consent, Local Anaesthetic allergy, Patients requiring more than one attempt for intravenous cannulation.

结局指标

主要结局

Pain visual analog scale (VAS)score

时间窗: 0 minute: At the time of local anaesthetic prick/vapocoolant spray | 1 minute : After local anaesthetic prick/vapocoolant spray at the time of IV cannulation | 2 minutes : After local anaesthetic prick/vapocoolant spray

次要结局

  • Anxiety visual analog scale (VAS) score(Heart rate (HR))

研究者

发起方
Dr Shagun Bhatia Shah
申办方类型
Other [self]

研究点 (1)

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